Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
Immunogenicity and Safety of Co-administration of Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine With 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years: A Randomized, Non-inferiority Trial.
СтатьяРандомизированное исследованиеEquivalence TrialКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Leroux-Roels Isabel, Lins Muriel, Surowitz Ronald, Pragalos Antoinette, Jua Paulia Kwo Ton Ge, Wauters Dominique, Jayadev Amulya, Akite Jacqueline Elaine, Jastorff Archana M, Cárdenas Vicky, Van der Wielen Marie, RSV-019 study group
Аннотация
BACKGROUND: Respiratory syncytial virus (RSV) illness and pneumococcal disease present high disease burden and health risks to older adults. Vaccination against these 2 illnesses is a key strategy to reduce this burden, and co-administration of the 2 vaccines could enhance vaccine uptake. This study evaluated the immunogenicity, safety, and reactogenicity of co-administration of adjuvanted RSV prefusion F protein vaccine (adjuvanted RSVPreF3) with 20-valent pneumococcal conjugate vaccine (PCV20) in adults aged ≥60 years.
METHODS: This phase III, open-label, randomized, non-inferiority trial was conducted across 38 centers in Belgium, Poland, Spain, and the United States. Participants (N = 1112) were randomized 1:1 to receive adjuvanted RSVPreF3 vaccine and PCV20 vaccine either concomitantly (Co-Ad group) or 1 month apart (Control group). The primary objectives were to assess immunogenicity as measured by RSV-A and RSV-B neutralizing titers and opsonophagocytic titers for the PCV20 serotypes. Safety and reactogenicity were assessed as secondary objectives.
RESULTS: All primary immunogenicity objectives were met. The upper limit of the 95% confidence interval of the geometric mean titer ratios for RSV-A, RSV-B, and all 20 PCV20 serotypes was within the pre-defined non-inferiority margins. Safety profiles were similar across both groups, with most adverse events being mild to moderate in severity and of short duration. Serious adverse events and potential immune-mediated diseases were rare and unrelated to vaccination.
CONCLUSIONS: Co-administration of adjuvanted RSVPreF3 vaccine and PCV20 vaccine in older adults is immunologically non-inferior to their sequential administration, with an acceptable safety profile. These findings support co-administration as a strategy to enhance vaccine uptake.
CLINICAL TRIALS REGISTRATION: NCT05879107.
METHODS: This phase III, open-label, randomized, non-inferiority trial was conducted across 38 centers in Belgium, Poland, Spain, and the United States. Participants (N = 1112) were randomized 1:1 to receive adjuvanted RSVPreF3 vaccine and PCV20 vaccine either concomitantly (Co-Ad group) or 1 month apart (Control group). The primary objectives were to assess immunogenicity as measured by RSV-A and RSV-B neutralizing titers and opsonophagocytic titers for the PCV20 serotypes. Safety and reactogenicity were assessed as secondary objectives.
RESULTS: All primary immunogenicity objectives were met. The upper limit of the 95% confidence interval of the geometric mean titer ratios for RSV-A, RSV-B, and all 20 PCV20 serotypes was within the pre-defined non-inferiority margins. Safety profiles were similar across both groups, with most adverse events being mild to moderate in severity and of short duration. Serious adverse events and potential immune-mediated diseases were rare and unrelated to vaccination.
CONCLUSIONS: Co-administration of adjuvanted RSVPreF3 vaccine and PCV20 vaccine in older adults is immunologically non-inferior to their sequential administration, with an acceptable safety profile. These findings support co-administration as a strategy to enhance vaccine uptake.
CLINICAL TRIALS REGISTRATION: NCT05879107.
Предметные рубрики MeSH
HumansPneumococcal VaccinesRespiratory Syncytial Virus VaccinesAgedMaleAntibodies, ViralFemaleRespiratory Syncytial Virus InfectionsMiddle AgedViral Fusion ProteinsImmunogenicity, VaccineRespiratory Syncytial Virus, HumanAdjuvants, ImmunologicPneumococcal InfectionsVaccines, ConjugateAged, 80 and overAntibodies, Neutralizing